BEUDAMED
    FDA Adverse Event Other Summary report: N

    INVISION-PLUS NEURTAL

    MDR report key: 1898455 · Received November 9, 2010

    Report

    Report Number
    MW5018134
    Event Type
    Other
    Date Received
    November 9, 2010
    Date of Event
    October 30, 2010
    Report Date
    November 1, 2010
    Manufacturer
    RYMED TECHNOLOGIES, INC.
    Product Code
    FPA
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    RYMED INVISION-PLUS NEURTAL WITH A LOT NUMBER OF R00420 WAS FOUND TO HAVE A BROKEN PIECE OF CENTER CORE IN MICRO IV TUBING AFTER RUNNING IV POTASSIUM VIA A CENTRAL LINE. EQUIPMENT WAS KEPT AND WILL BE SENT TO THE MFR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INVISION-PLUS NEURTAL FPA RYMED TECHNOLOGIES, INC. R00420

    Patients

    Seq Age Sex Outcome Treatment
    1 19 MO